Retrospective Data Collection of Routine Use With Spectra Optia® for Platelet Depletions

Myeloproliferative Disease Clinical Trial

— PLTD  

Official title:

Multicenter, Retrospective Data Collection of Routine Clinical Use With the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308787
• Other study ID #: CTS-5052
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: May 6, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Terumo BCT
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial Summary

Multicenter, Retrospective Data Collection of Routine Clinical Use with the Spectra Optia® Apheresis System for Platelet Depletion Procedures.

Description:

This is a multicenter, retrospective data collection to evaluate the in routine use performance and safety of platelet depletions performed via the Spectra Optia system. Data collection will include procedures in 2- 3 different centers in Europe done between November 2011 and April 2014.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients having received a minimum of one platelet depletion procedure via the Spectra Optia system.

• Availability of complete blood count results prior to starting and after completing the platelet depletion procedure via the Spectra Optia system.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Myeloproliferative Disease
• Myeloproliferative Disorders
• Thrombocythemia
• Thrombocytopenia
• Thrombocytosis

Intervention

Device:
• Spectra Optia Apheresis System
Platelet Depletion

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Hungary	University of Pécs	Pécs

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCT

Countries where clinical trial is conducted

Denmark,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent decrease in platelet count in patient blood following apheresis procedure		on average this will be within 15 minutes after the end of the procedure	No
Primary	percent of processed platelets which are collected i.e. collection efficiency for platelets achieved by Spectra Optia.		on average this will be within 15 minutes after the end of the procedure	No
Primary	adverse events		during the apheresis procedure (from the moment the patient is connected until he is disconnected from the device) and device or procedure related adverse events until discharge from Apheresis Unit (On average, half hour after end of procedure).	Yes